Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
REGULATORY
US FDA, EMA Hold Monthly Regulatory Working-Level Talks, with Participation of PMDA as Observer
The US FDA and the European Medicines Agency (EMA) have announced that the two parties will hold a joint conference in order to discuss pharmacovigilance topics. The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the Canadian regulatory authority Health…
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REGULATORY
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